Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1994-08-18
1998-11-17
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424435, 424465, 424474, 424479, 424480, 424482, A61K 920
Patent
active
058372857
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a drug-containing fast soluble tablet that dissolves rapidly in the oral cavity.
The fast soluble tablet usually dissolves in the oral cavity within 15 seconds to 3 minutes, and is suitable for administration to infants, the aged, severely affected patients and others who have difficulty in taking tablets.
BACKGROUND ART
Oral dosage forms of drugs include tablets, granules, powders and liquids. Liquids, such as syrups, are suitable for administration to the physically weakened aged and infants because they are easily swallowable. However, they are not convenient because they must be accurately weighed for each use. Another drawback is that the tendency to deteriorate easily upon exposure to heat or atmosphere degrades the drug's chemical and physical stability.
Granules and powders are free of the above drawbacks, but they are not easily swallowable, and taking the accurate dose is difficult unless they are taken with water etc.
Tablets are suitable for administration of a certain accurate volumes and offers excellent chemical and physical stability for the drug contained, but they have a drawback of difficult swallow for infants, the aged, severely affected patients and others. Overcoming the drawback of poor swallowability would make it possible to provide an excellent preparation free of the above-described drawbacks in other dosage forms.
As a solution to the problem of poor swallowability in tablets, freeze-dried preparations in a tablet form, based on a water-soluble polymer, have recently been developed (e.g., Japanese Patent Unexamined Publication Nos. 44619/1978 and 86837/1991). They have overcome the drawback of poor swallowability in tablets by causing the preparation to dissolve rapidly in the oral cavity. However, they require a special preparation technology known as freeze-drying, resulting in drawbacks such as difficulty in industrial mass-production, high production cost and poor physical stability.
In recent years, tablets have been produced by subjecting tablet components to compressive shaping under high pressure in a dry state. This is because tablets are essentially intended to be disintegrated in the gastrointestinal tract to cause drug absorption and must be physically and chemically stable from completion of tableting to reach to the gastrointestinal tract, so that the tablet components must be strongly bound together by a compressive pressure. In early times, wet tablets were available, which were molded and shaped into tablets while in a wet state, followed by drying. However, such tablets were not rapidly soluble in the oral cavity because they were intended to be disintegrated in the gastrointestinal tract. Also, as these tablets are not strongly compressed mechanically and lack shape retention, they are not practically applicable to modern use.
DISCLOSURE OF THE INVENTION
The object of the present invention is to provide a fast soluble tablet that can be produced by a simple method without the above-described special preparation technology known as freeze-drying.
Through intensive investigation, the present inventors found that the above object could be accomplished by producing tablets based on a pharmaceutical additive rapidly soluble in water by a modification of the conventional tableting method based on wet granulation and completed the present invention.
A gist of the present invention is characterized by two features: 1) the tablet base component is a pharmaceutical additive rapidly soluble in water, and 2) a kneaded mixture of a drug and a pharmaceutical additive rapidly soluble in water is subjected to compressive shaping while in a wet state.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1-4 show the relationship between tensile strength, oral cavity, dissolution time and compression force for the inventive tablets.
The present invention is hereinafter described in detail.
The pharmaceutical additive rapidly soluble in water may be any water-soluble crystalline or powdery solid, exemplified by substances in common
REFERENCES:
patent: 5073374 (1991-12-01), McCarty
patent: 5073380 (1991-12-01), Babu et al.
patent: 5082667 (1992-01-01), Van Scoik
patent: 5112616 (1992-05-01), McCarty
patent: 5234696 (1993-08-01), Van Scoik et al.
patent: 5288501 (1994-02-01), Nurnberg et al.
patent: 5501861 (1996-03-01), Makino et al.
Izumi Shogo
Nakamichi Kouichi
Yasuura Hiroyuki
Howard Sharon
Page Thurman K.
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